Myalgic Encephalomyelitis (ME)

Promises, Promises: Thirty Years of NIH Broken Promises

The pattern of 30 years of NIH broken promises to the myalgic encephalomyelitis (ME) community is continuing unhindered. Representatives of the NIH ME/CFS Clinical study and the Trans-NIH Working Group make empty, insincere promises. They assure us that our voice and input is essential when in reality their actions entirely dismiss our view. More alarmingly, it has become apparent as of late that those at NIH responsible for ME research, doubt the biological nature of the disease. This unscientific hypothesis will affect every process that NIH takes and the result would adversely affect ME patients for a long time to come.

Recently, ME patients and advocates raised critical concerns with the NIH ME/CFS Study (see MEadvocacy blog: NIH Sidesteps Critical Problems with the ME/CFS Study). NIH refused to move on adopting the many recommendations outlined to them, some of which were: to include the patients and advocates’ voice in every step of the study starting from the planning stages, removal of problematic NIH investigators who believe that the disease is a somatoform disorder, initiating, and maintaining a transparent and two-way communication process between NIH and the ME community (researchers, clinicians, advocates and patients).

A petition started by MEadvocacy, signed by 750 ME community members, and delivered to NIH Director Francis Collins on February 15, 2016, calling for the cancellation of the proposed NIH ME/CFS Clinical Study and restarting with input from the ME community of patients, advocates, researchers and clinicians was ignored and went unanswered.

The following is a more recent incident showing the same disrespect to the ME community.

Since November 3, 2016, the ME community has contested the scheduled appearance of the ME disease denier Edward Shorter as a lecturer on the history of ME/CFS at The National Institutes of Health Clinical Center in Bethesda, MD. Patients, advocates, researchers, and patient organizations wrote letters to NIH demanding the cancellation of Shorter’s controversial lecture because of his career of spreading unscientific postulations that ME/CFS is a” psychic epidemic” of women who are attention seekers.

Shorter’s lecture took place on November 9th as scheduled, despite mass protests from the ME community including researchers who tweeted and spoke out. Below is the reply sent by The Trans-NIH ME/CFS Working Group to the members of the ME community which is completely unresponsive and dismissive of the ME/CFS community’s opposition.

Dear members of the ME/CFS community,

You have written to express concern about the NIH lecture by Edward Shorter that took place on November 9th. Thank you for sending us your thoughts.

Please know that the lecture you asked about was not sponsored by either the ME/CFS Special Interest Group or the Trans-NIH ME/CFS Working Group, which means that it does not reflect the ideas, opinions, or policy of the NIH or the scientists now working on this disease. Given the professional and learning environment that NIH promotes, dozens of people come each week to the NIH to exchange ideas with NIH scientists; the scientists who attend these lectures frequently challenge or disagree with the speakers’ ideas. In scientific circles, disagreement with what is said is often more scientifically productive than agreement. The exchange of information and divergent opinions, followed by critical analysis, is essential to moving any field forward. The most important thing that we wish to share is that NIH remains firmly committed to using scientific methods to uncover the biological mechanisms that cause ME/CFS and to improve the lives of people who have been suffering for years, and even decades. Comments made in a seminar will not undermine the progress of science at NIH.

Several of you have asked why the lecture was not mentioned during the telebriefing that NIH hosted on November 2nd. The telebriefing was intended to discuss the efforts of the Trans-NIH ME/CFS Working Group and the progress made in initiating the NIH Intramural research clinical study. The lecture was not part of those efforts.

The speaker shared his viewpoint, the scientists who attended asked questions, and perspective was provided by a patient and a community physician. The lecture was attended by approximately 15 scientists, including some who are part of the clinical study investigative team. It is fair to say it will have no impact on NIH’s interest in doing everything we can to advance the science of ME/CFS.

Regards,

The Trans-NIH ME/CFS Working Group

If you pay close attention to the exact verbiage used in this reply, you will see a prime example of government “double-speak” in an attempt to cover up their transgression.

“The lecture you asked about was not sponsored by either the ME/CFS Special Interest Group or the Trans-NIH ME/CFS Working Group”.

The use of the word “sponsored” is deceptive. It implies that the ME/CFS Special Interest Group or the Trans-NIH ME/CFS Working Group didn’t pay for Shorter’s lecture but, it doesn’t tackle the question of who extended the invitation.

“Which means that it does not reflect the ideas, opinions, or policy of the NIH or the scientists now working on this disease”

The fact that they didn’t “sponsor” Shorter’s lecture does not qualify as proof that it doesn’t reflect the opinions of NIH investigators. We are keenly aware and have spoken out about the fact that NIH researchers Drs. Walitt, Gill and Saligan, share Shorter’s beliefs that ME is a somatoform disorder. Dr. Walitt has repeatedly quoted and referenced Dr. Shorter in his works and was the one who introduced Shorter at the lecture at NIH.

“In scientific circles, disagreement with what is said is often more scientifically productive than agreement.”

Yes – a scientific debate is useful and fruitful. The only problem is that there is nothing scientific about Dr. Shorter’s false beliefs about ME. It is based on a fantastical myth created in Shorter’s warped mind.

“The most important thing that we wish to share is that NIH remains firmly committed to using scientific methods to uncover the biological mechanisms that cause ME/CFS.”

In reality, NIH has not followed through with their words. NIH refused to remove investigators who share Dr. Shorter’s psychogenic views of the disease from the clinical study. In his recent reply to the community, Dr. Koroshetz expresses that Shorter’s viewpoint about ME being psychosomatic is a valuable possibility.

“The speaker shared his viewpoint, the scientists who attended asked questions, and perspective was provided by a patient and a community physician.”

Before the lecture, NIH representatives stated that this speech was exclusively for NIH intramural investigators. Outsiders were not permitted to attend. Somehow one patient and one community physician were present for Shorter’s lecture. Were they used as token representatives so that NIH can “claim” community involvement?

The most important takeaway from this experience is that regardless of whose idea it was to invite (all signs point to Dr. Walitt) Shorter to lecture NIH investigators or who actually “sponsored” it, no one at NIH acted on our opposition and canceled the talk.

Additionally, this ME denier’s fabricated history of ME/CFS which he perceives as a psychogenic social female condition, masked the real history of myalgic encephalomyelitis – starting with several global outbreaks which attest to an infectious component of the disease. We have many ME historians who are well prepared to lecture about the real historical path of ME. Professor Malcolm Hooper has written extensively about the history of ME. Dr. Byron Hyde is an accomplished author writing about the history of ME as well as the science. Investigative journalist Hillary Johnson authored the acclaimed book Osler’s Web – a well-documented detailed account of the history of the disease. Hillary currently maintains a subscription-based news page, The Eye View, that covers people, politics and scientific developments in the field of ME. History professor, advocate, and patient Dr. Mary Schweitzer is currently writing a book on the history of ME and maintains a blog site, Slightly Alive, where she writes extensively about the historical facts and current events in ME.

Despite Walitt’s psychogenic bias of ME, NIH has refused to remove him from the NIH ME/CFS Clinical Study. Instead, NIH keeps praising him as in the NIH call November 2 with advocates. Dr. Nath replying to a question asked by patient advocate Eileen Holderman regarding Walitt remaining in the study replied: “And then Dr. Walitt, yes. So Dr. Walitt is a, you know, delightful individual, very experienced. I have full confidence in him. And so he’s doing a superb job putting this protocol together. He has done all the work in helping me.”

HHS’ disregard of the ME community has become a contemptible pattern – signifying a widespread institutional bias. Although HHS claims that things have changed, their actions disprove their words.

They disregarded and continue to ignore the ME community’s call for:

Adopting and using the correct historical name for the disease – myalgic encephalomyelitis

Adopting and using criteria created by our ME experts (CCC, ICC and Ramsay’s)

Appropriate funding commensurate with similarly burdened diseases – minimum of $250 million annually ($7 million annual increase is an insult and will not accomplish what is scientifically needed)

Proper education about the neuro-immune disease ME (not a fatiguing or somatoform disorder)

Real input from ME patients and advocates into the process (as opposed to just a perceived seat at the table)

It is time to reevaluate this broken relationship which is based on false promises, deception, and mistreatment. There is no urgency emerging from NIH in the face of this disabling disease that leaves an estimated million American men, women and children disabled, with no end in sight – many die in their youth, the rest die an average of 20 years early! Promised RFAs for ME research are delayed by two years, and the amount of money involved remains a mystery. The increase in extramural funding (which typically consists of 90% of NIH funding) is a meaningless increase of $7 million for 2017.

We cannot sit by and allow to this slow paced distribution of crumbs to continue. Some in the ME community are so angered by the repeated betrayal by NIH that they are calling for a complete withdrawal – aggressive refusal.

I agree with this aggressive refusal. We have witnessed the danger of federally funded research by investigators who favor the psychogenic view of the disease with the cataclysmic PACE trial and numerous other such studies by CDC. When all “a seat at the table” means is to enable the government to claim they gave us an opportunity for input yet they never act on our advice and requests – it is time to step away from this falsely implied collaboration and get our congressional representatives involved in advocating on our behalf.

A congressional investigation as promoted by Dr. Davis of the Open Medicine Foundation might be the only way for us to finally gain respect, equality and fair treatment by the US government health agencies. ME advocates should rise and stand up for the rights of ME patients. Looking away and accepting abuse only reinforces more of the same. We cannot allow this institutional bias to continue with disregard, negligence, and inequality, causing substantial harm to ME patients.

Quote: Somehow one patient and one community physician were present for Shorter’s lecture. Were they used as token representatives so that NIH can “claim” community involvement?

What are the names of that “one patient” and “one community physician”? It is time we know who the people are who are selling out the interests of other patients in order to gain NIH favor for themselves and their organizations. After 30 years of abuse, it is high time to name names.

If you want to see more details that are not included in the edited report that ME Action had published, I would suggest joining the two places I know of that Loetta had posted details of the report she sent ME Action: closed FB group named SEID https://www.facebook.com/groups/1607972529434703/ and then there was an ME Action group where she was posting information that she mentioned in the SEID group. There maybe other locations I am not aware of, I am only familiar with the SEID group.

FWIW, my book, an academic, thorough systematic demolishing of the edifice of psychogenic explanations, especially for ME/CFS, available since 2012, shows exactly why Shorter’s beliefs, among others, are untenable and fallacious. I actually engage with his notions and give a very rigorous critique (among many in the book). If more people could mention me, an academic, and the work I have done in this area, as a key resource when discussing the problem above (including with the NIH itself and Wallitt’s part in this), my book could be an extremely powerful weapon for this community. As it is, it’s ignored, and the forensic case I have built is under-used at best. My work is the most comprehensive and in-depth critique of psychogenic explanations for this illness so far. It’s really strange therefore, that it is so often (nearly always) excluded from discussions, even within the community itself. Instead, I have been subject to abuse from people like James Coyne (apparently BECAUSE of my ideas), with tacit acceptance of such abuse by many, most even. I’m not asking to be treated as a celebrity, or even some expert to be fawned over (many who know me will know I am very critical of our tendency as a community to do this to people). But engaging and publicising my book could be such a game changer for this community. However so far the opportunity has just not been taken by it.

You are correct in stating that your book is an essential resource for our ME community when encountering the likes of Shorter and Walitt with their psychogenic theories of this illness. The focus of this blog was NIH’s malfeasance regarding Shorter’s lecture at NIH. But, I agree with you that any discussion of the dangers and unscientific facts about the somatization theories of the disease should reference your book.

From an intro to your book: “Nevertheless, psychogenic explanations for illnesses still appear frequently within medical and academic literature, in “common sense” public discourses, and in medical diagnoses of patients. But how plausible are these explanations? Authors of our Own Misfortune? proposes that psychogenic explanations for physical illnesses are subject to a complex mix of confusing concepts, accompanied by certain moralistic and ideological assumptions about people and their illnesses. Most crucially, such explanations are also, almost always, fatally flawed, both scientifically and logically.”

Thank you for taking the time to bring to light this further evidence of the systemic bias at NIH.

I am more than a little concerned (dismayed/angry) that Edward Shorter was invited to speak at all. We have many who can speak to the history as noted in the article as well as Angela Kennedy’s work (see previous comment) who would be valuable to the conversation at NIH.

There is really no excuse NIH can give that will explain away this presentation by a man who thinks ME is attention seeking.

Thank you for your excellent and accurate post, Gabby! It should be clear nothing has changed at the NIH except the rhetoric. With regards to the neurological disease ME, US and WHO ICD G93.3, the NIH continues to place self-serving politics above sound science. The proposed NIH “ME/CFS” study shows a pre-existing, unscientific bias in these ways:

1. The failure to call the disease studied unambiguously ME rather than using the ambiguous, and now unintelligible, term “ME/CFS.” What use is a medical science research study if it is unclear what disease is being studied?

2. The proposed used of the unscientific, non-ME, non-research HHS/IOM “SEID” criteria. As ME doctor Derek Enlander wrote after the IOM ME/CFS report was published in 2015:

“The criteria that are quoted are a truncated version of the Canadian Consensus Criteria (CCC), truncated in a manner that allows the over-diagnosis of the disease. These criteria would also allow the diagnosis to include psychiatric conditions that are specifically excluded by both the Fukuda and CCC.”

Why in the world would any scientist agree to use the hopelessly flawed, untested, nonspecific HHS/IOM diagnostic criteria to select subjects for a research study? The only answer is that the researchers selected are unknowledgeable or biased about ME and place pleasing HHS bureaucrats above doing good science.

The NIH obviously intends to use their proposed “ME/CFS” study as a public relations opportunity to promote the faulty “SEID” criteria developed under HHS bureaucratic control. Use of the unscientific HHS/IOM criteria in research can only create chaos and impede progress in understanding ME for untold years to come.

3. The inclusion of the biased, crackpot psychogenic theory enthusiast Brian Walitt as a lead investigator, regardless of how “delightful” and “helpful” he may be, shows continued bad faith and psychogenic bias at the NIH towards ME.

No one should be fooled into believing that the NIH is helping anybody but themselves with any new “ME/CFS” research as proposed.